Objective Perfusion Rate Assessment by Near-infrared Fluorescence in Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

NCT04695964 | Unknown

• 1 other identifier: EA4/116/19/2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. Postoperatively, a detailed software-based assessment of each pouch recording is performed to determine the objective ICG-NIRF perfusion rate, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.

Conditions

Ulcerative Colitis; Colorectal Cancer; Crohn Disease; Familial Adenomatous Polyposis; Ulcerative Colitis in Remission; Ulcerative Colitis Chronic; Crohn Colitis; Ileal Pouch

Keywords

indocyanine green; restorative proctocolectomy; ileal pouch-anal anastomosis; objective perfusion rate; near-infrared fluorescence; ulcerative colitis; anastomotic leak; pouchitis; image guided surgery

Outcome Measures

Primary Outcomes (1)

• anastomotic leak

  occurence anastomotic leak within 30 days of operation

  30 days

Secondary Outcomes (2)

• Operative and post-operative complications

  30 days

• Length of post-operative hospital stay

  100 days

Study Arms (1)

ICG-NIRF Imaging and objective perfusion rate

OTHER

ICG-NIRF imaging is used to visualise the blood supply and the bowel perfusion rate in the area of the pouch anastomoses. An additional ingress and egress analysis at specific regions of interest is performed. This is to get an objective method of visualisation of the blood inflow and outflow over time and thus bowel perfusion at the anastomotic site.

Diagnostic Test: ICG-NIRF Imaging plus ingress and egress analysis

Interventions

ICG-NIRF Imaging plus ingress and egress analysis DIAGNOSTIC_TEST

intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3) Additional ingress and egress analysis (inflow and outflow analysis) of specificities regions of interest at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3)

ICG-NIRF Imaging and objective perfusion rate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18
• capability of signing the informed consent
• diagnosis of therapy resistent ulcerative colitis, colorectal cancer, Crohn's disease, familial adenomatous polyposis
• restorative proctocolectomy (RPC) with reconstruction through ileal pouch formation and ileal pouch-anal anastomosis (IPAA) is possible and medically indicated
• ASA (American Society of Anesthesiologists) Physical Status Classification System score ≤ 3

You may not qualify if:

• coexistent malignant tumor of a different ethology
• liver disfunction (MELD score \> 10)
• pregnancy or breastfeeding

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Campus Benjamin Franklin

Berlin, 12203, Germany

RECRUITING

Related Publications (6)

• van den Bos J, Jongen ACHM, Melenhorst J, Breukink SO, Lenaerts K, Schols RM, Bouvy ND, Stassen LPS. Near-infrared fluorescence image-guidance in anastomotic colorectal cancer surgery and its relation to serum markers of anastomotic leakage: a clinical pilot study. Surg Endosc. 2019 Nov;33(11):3766-3774. doi: 10.1007/s00464-019-06673-6. Epub 2019 Feb 1.

  PMID: 30710314 BACKGROUND

• McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19.

  PMID: 25703524 BACKGROUND

• Perbeck L, Lindquist K, Proano E, Liljeqvist L. Correlation between fluorescein flowmetry and laser Doppler flowmetry. A study in the intestine (ileoanal pouch) in man. Scand J Gastroenterol. 1990 May;25(5):520-4. doi: 10.3109/00365529009095524.

  PMID: 2163097 BACKGROUND

• Hallbook O, Johansson K, Sjodahl R. Laser Doppler blood flow measurement in rectal resection for carcinoma--comparison between the straight and colonic J pouch reconstruction. Br J Surg. 1996 Mar;83(3):389-92. doi: 10.1002/bjs.1800830330.

  PMID: 8665202 BACKGROUND

• van den Bos J, Al-Taher M, Schols RM, van Kuijk S, Bouvy ND, Stassen LPS. Near-Infrared Fluorescence Imaging for Real-Time Intraoperative Guidance in Anastomotic Colorectal Surgery: A Systematic Review of Literature. J Laparoendosc Adv Surg Tech A. 2018 Feb;28(2):157-167. doi: 10.1089/lap.2017.0231. Epub 2017 Nov 6.

  PMID: 29106320 BACKGROUND

• Degett TH, Andersen HS, Gogenur I. Indocyanine green fluorescence angiography for intraoperative assessment of gastrointestinal anastomotic perfusion: a systematic review of clinical trials. Langenbecks Arch Surg. 2016 Sep;401(6):767-75. doi: 10.1007/s00423-016-1400-9. Epub 2016 Mar 11.

  PMID: 26968863 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Colorectal Neoplasms; Crohn Disease; Adenomatous Polyposis Coli; Anastomotic Leak; Pouchitis

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases; Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ileitis; Enteritis; Ileal Diseases

Central Study Contacts

Benjamin Weixler, PD MD

CONTACT

+49 30 450 622 798; benjamin.weixler@charite.de

Leonard Lobbes, MD

CONTACT

+49 30 450 622 789; Leonard.lobbes@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Assistant Professor

Model Details: This is a non-randomised prospective cohort study design.

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 6, 2021
• Study Start: February 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

DE (1)